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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | MCLA-129 (EGFR inhibitor, c-MET inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Phase 1/2 study of MCLA-129 in patients with NSCLC and other solid tumors
Excerpt:
...Patients must have:- Non-small cell lung cancer (NSCLC) harboring activating EGFR mutations including tyrosine kinase inhibitor (TKI) sensitizing mutations (e.g., 19del and L858R), and/or approved TKI-resistance mutations (e.g., acquired TKI-resistance mutations, i.e., T790M, C797S, L792, L798I, exon 20 insertion), or any activating c-MET mutation/amplification (e.g., high-level c-MET amplification [MET/CEP7 > 5 or cfDNA ≥ 2 copies], or c-MET exon 14 skipping mutation).- Gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma harboring an EGFR amplification (EGFR/CEP7 ≥2 or cfDNA ≥ 8 copies) or c-MET amplification (MET/CEP7 > 5 or cfDNA ≥ 2 copies).- Head and neck squamous cell cancer (HNSCC) or esophageal squamous cell cancer (ESCC).*NOTE: Patient identification will be based on previous treatment history with EGFR tyrosine kinase inhibitors and on local tests performed in CLIA-certified laboratories.• Cohort Expansion Part - Patients who have failed prior standard first-line treatment. ...
Trial ID:
Source:
Title:
MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors: an ongoing phase 1/2 study
Published date:
10/12/2022
Excerpt:
Preliminary anti-tumor activity has been observed, including one confirmed and one unconfirmed partial response in EGFR mt NSCLC, 4 confirmed stable disease and 38.5% (5 out of 13 pts) confirmed disease control rate….MCLA-129 is well tolerated and has a favorable safety profile, with no reductions or discontinuations due to toxicity. Initial signals of efficacy were observed.
Trial ID:
